Glofil-125 Injection, Solution
NDC Package 50914-7729-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Glofil-125 (sodium iothalamate i-125 injection) injection is gLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease. This formulation utilizes a injection, solution delivery system. Marketed by Iso-tex Diagnostics, Inc., this product is identified by NDC 50914-7729 and is authorized under FDA application NDA017279.

Identification & Billing

NDC Package Code
50914-7729-2
Package Description
1 VIAL, MULTI-DOSE in 1 BOX / 4 mL in 1 VIAL, MULTI-DOSE
Product Code
50914-7729
11-Digit Billing Format
50914772902

Clinical Specifications

Proprietary Name
Glofil-125
Non-Proprietary Name
Sodium Iothalamate I-125 Injection
Substance Name
Iothalamate Sodium I-125
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
IOTHALAMATE SODIUM I-125 .275 mCi/mL
Pharmacologic Class
Usage Information
GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.

Regulatory & Marketing

Labeler Name
Iso-tex Diagnostics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017279
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-1983
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50914-7729-2 identifies a specific commercial package of 1 vial, multi-dose in 1 box / 4 ml in 1 vial, multi-dose of Glofil-125, a human prescription drug labeled by Iso-tex Diagnostics, Inc.. This injection, solution is formulated for intravenous use and contains iothalamate sodium i-125 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Iso-tex Diagnostics, Inc. on May 01, 1983. The current certification is valid through December 31, 2026.

How is this Iso-tex Diagnostics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50914772902. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
50914-7729-2
11-Digit CMS (5-4-2)
50914-7729-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.